Webinar: Current Status of RBC Component Viability Requirements

Webinar Overview

This webinar provides insight into the key attributes and in vitro characteristics for stored red cell components for transfusion. It also addresses the question of how the in vivo acceptance criteria for regulatory approval of stored red cell components were derived.   The speakers also describe the state-of-the-art in red cell preservation and review future directions.

Dr. Jose A. Cancelas, gives a brief review of red cell physiology and describes the effects of RBC storage on traditional biochemical means of erythrocyte characterization.  These parameters are surrogate indicators of anticipated physiologic performance of the red cell when transfused as a therapeutic intervention.   Dr. Cancelas then examines the development of red cell storage solutions and looks at some of the experimental additive solutions (EAS).  Future directions proposed include conducting additional well-designed studies to determine the safety of stored RBC.

Larry J. Dumont, PhD, summarizes the performance requirements for clinical trials of red cell systems.  Dr. Dumont describes how “24-hour recovery” has become, for all practical purposes, the sole in vivo determinant of importance to US regulatory officials.  The factors that affect this measurement are evaluated in detail in a discussion of the BEST study (“Biomedical Excellence for Safer Transfusion”, Transfusion 2008 48:1053-1060).  Also presented is a critical evaluation of the likelihood that current red cell storage and treatment methods (such as gamma-irradiation for the prevention of GvHD) would meet existing FDA licensure requirements.

Advancements in the formulation of red cell additive solutions have conferred many advantages, but questions still remain regarding which characteristics are critical in evaluating existing, new or modified red cell storage systems.  Clearly, pathogen inactivation systems will need to preserve the safety and therapeutic efficacy red cell components.  Understanding which parameters are clinically relevant is an essential step in optimizing these processes.

 Speaker Bio

Larry Dumont, MBA, Ph.D Assistant Professor of Pathology, Dartmouth Medical School Hanover, New Hampshire, USA Larry received his BS in Biology at Regis College, Denver, and MBA from the University of Phoenix. He was awarded a PhD in Clinical Sciences at the University of Colorado Health Sciences Center in Denver where he received training in biostatistics and epidemiology. He has four years clinical background in Pediatric Dialysis at the University of Colorado. Larry spent 25 years with COBE Laboratories / Gambro BCT as an engineer and manager in Quality Assurance and as a scientist in R&D. In the latter position he was the project leader for 7-day platelets and the PASSPORT Study. Currently, Larry is Assistant Professor of Pathology at Dartmouth Medical School and Director of the Cell Labeling Laboratory. He has extensive experience in experimental design and data analysis both in the industrial and clinical settings. His current interests are in platelet physiology, in vivo cell survival kinetics, and clinical outcomes in transfusion medicine.

Jose A. Cancelas, M.D., Ph.D Director Research Division, Medical Director Cellullar Therapies Hoxworth Blood Center Cincinnati, OH, USA Dr. Cancelas is Associate Professor, Department of Pediatrics, UC, Division Director of Research, and Medical Director of Cellular Therapies at the Hoxworth Blood Center. His specialty is Hematology with a subspecialty in Transfusion Medicine. He has over 15 years experience in clinical and basic research, and has been the PI of multiple research projects in Transfusion Medicine and Cell Therapies. His clinical research in Transfusion Medicine is located at Hoxworth Blood Center, and includes product development, pre-clinical, and Phase I and II clinical trials for private companies and the Department of Defense. His basic/translational research in hematopoietic stem cell biology is based in Cincinnati Children's Hospital and is currently funded by the NIH, DoD, and private foundations.

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